Smith+Nephew’s PICO Systems OK’ed for Closed Surgical Incisions

Smith+Nephew has gained new indications from the U.S. Food and Drug Administration (FDA) for its PICO 7 and PICO 14 single-use negative pressure wound therapy (sNPWT) systems. PICO 7 and PICO 14 can now be used on closed surgical incisions.
 
Using these SNPWT systems can help reduce superficial and deep incisional surgical site infections (SSIs) in Class I and II wounds for high-risk patients. It can also aid in preventing post-op seroma and dehiscence—the latter of which has a 9.6 percent mortality rate, can cause an average of 9.4 excess hospitalization days, and cost $40,323 in excess hospital costs relative to matched controls.
 
SSIs are responsible for about 8,000 deaths annually in the U.S.
 
“As a high-volume elective hip and knee replacement surgeon, I am sending more patients home the same day with outpatient surgery,” Dr. Bashyal, Director of Outpatient Total Joints at NorthShore University Health System, told the press. “The PICO System has been a game changer in managing closed incisions in my practice by helping to reduce the incidence of wound complications, including drainage, seromas, and superficial infections.”
 
To earn the new indication for use from the FDA, 25 studies enrolling 5,560 patients spanning caesarean section, orthopedic, and colorectal surgeries were held. Meta-analysis of these studies showed statistical efficacy compared to conventional dressings, including superficial and deep incisional class I and II wound SSI incidence. PICO also minimized post-op seroma and dehiscence.
 
According to the company, PICO sNPWT has been used on an estimated 2.3 million surgical incisions.